On June 18th, 2010, Doctor's Data, an organisation which conducts fraudulent medical tests on behalf of charlatans and crooks, filed suit against Dr Stephen Barrett of Quackwatch, the National Council Against Health Fraud, Inc., Quackwatch, Inc., and Consumer Health Digest, accusing them of restraint of trade, trademark dilution, business libel, tortious interference with existing and potential business relationships, fraud or intentional misrepresentation, and violating federal and state laws against deceptive trade practices. (On June 29th, Consumer Health Digest was dropped as a defendant.) The complaint asks for more than $10 million in compensatory and punitive damages. The suit objects to seven articles on Dr Barrett's web sites. Dr Barrett asked them on at least two occasions to specify the inaccuracies on his site, but of course they didn't (because they couldn't) and instead reached for lawyers. As a service to the public, and in case Dr Barrett is forced to remove the pages from his sites, here are the seven articles:

How the "Urine Toxic Metals" Test Is Used to Defraud Patients

Stephen Barrett, M.D.

Many patients are falsely told that their body has dangerously high levels of lead, mercury, or other heavy metals and should be "detoxified" to reduce these levels. This article explains how a urine test is used to defraud patients.

The report pictured to the right is a "urine toxic metals" test from Doctor's Data, a Chicago-based laboratory that caters to chelation therapists and other offbeat practitioners. The patient who gave it to me was told that his mercury and lead levels were high and should be reduced with EDTA chelation therapy.

The report classifies the man's lead and mercury levels as "elevated because they are twice as high as the upper limit of their "reference ranges." However, this classification is misleading because:

The report states that the specimen was obtained after patient was given a "provoking agent," but the reference range is based on non-provoked tests.

The levels, whether provoked or not, are not high enough to conclude that the patient has a problem that requires attention.

Even if a problem exists, chelation may not be the best course of action.

Doctor's Data also processes the urine toxic metals test for The Great Plains Laboratory, Inc., of Lenexa, Kansas. Urine toxic metal testing is also performed by Genova Diagnostics (Asheville, North Carolina) and Metametrix Clinical Laboratory (Duluth, Georgia).

Why Provoked Testing Is a Scam

Mercury is found in the earth's crust and is ubiquitous in the environment. Because of this, it is common to find small amounts in people's urine. The body reaches a steady state in which tiny amounts are absorbed and excreted. Large-scale population studies have shown that the general population has urine-mercury levels below 10 micrograms/liter, with most people between zero and 5 [1]. Similarly, many people circulate trivial amounts of lead.

Urine lead and mercury levels can be artificially raised by administering a scavenger (chelating agent) such as DMPS or DMSA, which attaches to lead and mercury molecules in the blood and forces them to be excreted. In other words, some molecules that would normally recirculate within the body are bound and exit through the kidneys. As a result, their urine levels are artificially and temporarily raised. How much the levels are raised depends on how the test is administered. The standard way to measure urinary mercury and lead levels is by collecting a non-provoked urine sample over a 24-hour period. Because most of the extra excretion takes place within a few hours after the chelating agent is administered, using a shorter collection period will yield a higher concentration.

When testing is performed, the levels are expressed as micrograms of lead or mercury per grams of creatinine (µg/g) and compared to the laboratory's "reference range." Well-designed experiments have demonstrated how provocation artificially raises urinary output.

One experiment involved ten healthy people whose urine was examined before and after receiving a 1-hour infusion of calcium disodium EDTA. The infusion increased the excretion of lead about 6 times over the baseline level [2].

Another experiment tested workers who had industrial exposure to mercury. The researchers reported that provocation with DMSA raised the 24-hour average urine mercury level from 4.3 µg/g before chelation to 7.8 µg/g after chelation [3].

Both of these studies used a 24-hour urine collection period. Because most of the extra excretion occurs toward the beginning of the test, it is safe to assume that the provoked levels would have been much higher if a 6-hour collection period had been used.

Practitioners who use the urine toxic metals test typically tell patients that provocation is needed to discover "hidden body stores" of mercury or lead. However, the above experiment proved that provocation raises urine levels as much in exposed workers as in unexposed control subjects and that rise is temporary, should be expected, and is not evidence of "hidden stores."

The "hidden stores" notion was further debunked by a study that compared non-provoked and DMSA-provoked urine specimens from 15 children with autism and 4 normally developing children who ranged from 3 to 7 years old [4]. After a baseline specimen from each child was collected, the DMSA was given in three doses over a 16-hour period, and the specimens were collected for 24 hours and tested for lead, mercury, arsenic, and cadmium. The testing was performed by the Mayo Clinic's laboratory, which used reference ranges of 80 ug/liter as the upper limit of normal and over 400 µg/liter for the lower limit of the potentially toxic range for lead and 10 µg/liter as the upper limit of normal and over 50 µg/liter for the lower limit of the potentially toxic range for mercury. All of the normal children and 12 of the autistic children excreted no detectable amount of any of the tested materials. In one child, DMSA provocation raised the urine lead level from undetectable to 6 µg/liter, which the researchers said was far too low to be of concern. In another child, the mercury level rose from undetectable to 23 µg/liter, but after fish was removed from that child's diet for more than a month, it fell to 5. The study showed that when laboratory measurements are accurate and proper reference standards are used, neither autistic nor normal children are likely to have problematic levels of lead or mercury, even when provoked testing is used, but fish-eaters might consume enough mercury to enable provocation to produce an inflated value.

Neither Mayo Clinic, nor any other legitimate national laboratory, has reference ranges for "provoked" specimens. Further, the references ranges for normal urine heavy metal levels used by Mayo Clinic and the largest national reference lab, Quest Diagnostics, are the same.

In contrast, Doctor's Data uses reference values of less than 3 ug/g for mercury and 5 ug/g for lead. Standard laboratories that process non-provoked samples use much higher reference ranges [4,5], which means that if all other things were equal, Doctor's Data is far more likely than standard labs to report "elevated" levels. But that's not all. A disclaimer at the bottom of the above lab report states—in boldfaced type!—that "reference ranges are representative of a healthy population under non-challenge or nonprovoked conditions." In other words, they should not be applied to specimens that were obtained after provocation. Also note that the specimen was obtained over a 6-hour period, not the standard 24-hour period, which raised the reported level even higher.

The management at Doctor's Data knows that provoked testing artificially raises the urine levels and that the length of collection time greatly influences the results. In 2002, David W. Quig, Ph.D. and two others presented a study of mercury levels in urine collected two hours after DMPS administration to 259 patients at a Nevada clinic. More than 75% of the patients tested at 21 µg or higher, and most of the rest fell between 3µg and 20 µg [6]. At these levels, nearly everyone's mercury level would be classified as "elevated" or "very elevated" on the test reports. In a 2006 naturopathic textbook chapter, Quig, who is Doctor's Data's vice president for scientific support, acknowledged that mercury levels "are higher in specimens collected from 90 minutes to 2 hours after DMPS infusion than with longer collection times, because the peak rate of mercury excretion occurs about 90 minutes after infusion of DMPS." [7] Quig's chapter also states:

There are no well-established guidelines for the interpretation of the results of the DMPS challenge test.

Conclusions about toxicity cannot be made from the DMPS test results alone. Consideration has to be given to the overall medical examination, medical and exposure history, and presenting symptoms.

DMPS does not provide direct information as to the level of mercury present in the central nervous system.

DMPS is not an FDA-approved drug.

Despite all of this, Doctor's Data's reports classify mercury values in the range of 5-10 µg/g as "elevated" and further state that "no safe reference levels for toxic metals have been established." Practitioners typically receive two copies of the report, one for the practitioner and one to give to the patient. Very few patients understand what the numbers mean. They simply see "elevated" lead or mercury, and interpret the "no safe levels" disclaimer to mean that any number above zero is a problem. The patient is then advised to undergo "detoxification" with chelation therapy, other intravenous treatments, dietary supplements, or whatever else the practitioner happens to sell.

This advice is very, very, very wrong. No diagnosis of lead or mercury toxicity should be made unless the patient has symptoms of heavy metal poisoning as well as a much higher nonprovoked blood level. And even if the level is in the 30s—as might occur in an unsafe workplace or by eating lead-containing paint—all that is usually needed is to remove further exposure. Chelation therapy is rarely necessary.

Chelation therapy is a series of intravenous infusions containing a chelating agent and various other substances. One form of chelation therapy is occasionally used to treat lead poisoning. However, lead poisoning is rare and has well-established diagnostic criteria. Slight elevations of lead levels are not poisoning and need no treatment because the body will lower them when exposure is stopped. Proper diagnosis of lead poisoning requires symptoms of lead poisoning, not just a slightly elevated level. Acute poisoning is always accompanied by a rise in zinc protoporphyrin (ZPP), without which it should not be diagnosed. Chronic poisoning would have severe symptoms that would be obvious to anyone in addition to severely elevated lead (and ZPP) levels.

Doctors who offer chelation therapy as part of their everyday practice typically claim that it is effective against autism, heart disease and many other conditions for which it has no proven effectiveness or plausible rationale [8]. One such case was described in a 2009 decision by the U.S. Court of Federal Claims which found no credible evidence that childhood vaccinations cause autism. In that case, Colton Snyder underwent chelation therapy after a Doctor's Data urine test report classified his urine mercury level as "very elevated." After noting that the urine sample had been provoked (with DMSA) and that provocation artificially increases excretion, the Special Master concluded that a non-provoked test would have placed the result in the normal range. He also noted:

The medical records, including reports from Mrs. Snyder, reflected that Colten did poorly after every round of chelation therapy. . . . The more disturbing question is why chelation was performed at all, in view of the normal levels of mercury found in the hair, blood, and urine, its apparent lack of efficacy in treating Colten’s symptoms, and the adverse side effects it apparently caused [9].

In March 2010, in a related case, another Special Master concluded that it made no sense to compare the child's post-provocation urine test result to a reference range that is based upon non-provoked urine testing. [10].

In March 2009, Arthur Allen tried to interview an official at Doctor's Data but received no response to his request. However, he did manage to talk with someone at the company who said that the lab was doing about 100,000 of the tests per year. When he asked about the reference range problem, he was told there was no way to establish a reference range for provoked specimens, because provocation might be done with various chelating agents, at varying doses. "The tests are ordered by physicians, so they can interpret the results," the employee said. "They do what they want with this information." [11]

Despite provocation, the toxic urine test report sometimes shows no elevated levels. But that doesn't deter the doctors who are intent on chelating children. They simply tell parents that the children have trouble excreting heavy metals and the test may not detect "hidden stores." In other words, no matter what the test shows, they still recommend chelation.

In 2004, CIGNA HealthCare Medicare Administration, which processes Medicare claims for Idaho, North Carolina, and Tennessee, issued a "Progressive Correction Action Review" which concluded that many claim submissions for chelation therapy had been inappropriate. This conclusion was documented by a study of 40 claims which found that in many cases, "heavy metal toxicity" was inappropriately diagnosed and no need for chelation with edetate calcium disodium was documented. The review criticized provoked testing and noted that it does not provide a basis for diagnosing past or current poisoning [12].

In 2009, the American College of Medical Toxicology (ACMT) issued a position statement which concluded that provoked testing on provoked testing "has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning." [13]

The Online Petition

Many parents have expressed concern about the way that Doctor's Data reports its findings. Several years ago, a petition was posted to petitiononline.com to ask Doctor's Data to stop comparing provoked tests results to non-provoked standards. By February 2006, there were 92 signers. The petition states:

To: To get matching reference ranges to people testedTo the CEO of Doctors data Inc.

We thank you for providing the extensive testing for toxic metals , fecal stools & all the other tests that us parents of children with autism and other disabilities have done at DDI.

However we would like to ask you to please use matching reference ranges to the people tested as it is impossible to get an accurate picture when the reference ranges do not match.

Eg. Urine toxic metals challenge test compares a childs urine sample AFTER provocation with DMSA to an UNPROVOKED reference range population of adults & kids. It is only natural that our kids will show results that are higher than the reference range.

Had the reference range population also been provoked, their results would have most probably been higher, which means our childrens results may not really be that high, it just appears that way.

The present tests compare apples to bananas.... provoked to unprovoked...we'd like to compare apples to apples please.

We the undersigned urge you to please seriously consider this petition and to give us matching reference ranges to the children tested as we need accurate test results in order to be able to do the correct treatments to get them better.

Sincerely,

The Undersigned

Regulatory Actions and Civil Suits

Several state licensing boards have taken action against doctors who used provoked urine testing as a prelude to chelation. In some of these cases, the test was of major importance in the public documents that describe the board actions. In the rest, the board action emphasized other misconduct and the test was either briefly mentioned or I learned of its relevance through other means. There have also been at least four civil suits.

in 2002, the Medical Board of California charged Ilona Abraham, M.D. with unprofessional conduct, incompetence, gross and repeated negligence, and inadequate recordkeeping in connection with her management two patients. In both cases, Abraham had failed to perform an adequate history and physical examination and had administered chelation therapy after diagnosing heavy metal toxicity based on provoked testing. In 2004, the case was settled by a consent agreement and order under which Abraham agreed to serve three years probation, during which time she would (a) pay about $26,000 for costs, (b) take certain remedial courses, and (c) engage the services of a practice monitor [14].

Connecticut has included a provoked testing ban in settlement agreements with two practitioners. In 2005, Robban Sica, M.D., signed a consent order under which she was prohibited from using a provoked test to diagnose heavy metal toxicity [15]. In 2006, George Zabrecky, D.C., was ordered to stop all testing that might be preliminary to chelation therapy [16].

In 2006, Washington's Bureau of Medical Quality Assurance charged Stephen L. Smith,M.D., with unprofessional conduct for relying on unreliable tests that included a urine toxic metals test. In 2007, he was ordered to pay a $5,000 fine and undergo a practice evaluation [17].

In 2007, Tennessee suspended the license of Joseph E. Rich, M.D., after concluding that he had mismanaged the care of 15 patients, including three who were chelated after undergoing a provoked urine test. [18].

In 2007, the Texas Medical Board charged William Rea, M.D. with (a) using pseudoscientific test methods, (b) failing to make accurate diagnoses, (c) providing "nonsensical" treatments, and (d) failing to properly inform patients that his approach is unproven. A urine toxic metals test was used in two of the five cases involved [19].

In 2007, the California Medical Board revoked the license of Alan Schwartz, M.D., as a result of several types of misconduct, including unsubstantiated diagnoses and unwarranted treatment of four children [20].

In 2007, the North Carolina Medical Board charged Rashid A. Buttar, D.O., with exploiting four patients by charging exorbitant fees for worthless tests and treatments. At a 2008 hearing, Buttar indicated that he recommends chelation for nearly all patients who consult him and routinely uses the urine toxic metals testing to evaluate them. In 2009, the charges were reasserted and four more cases were added [21,22]. Rather than getting into a lengthy and complicated legal battle, the case was settled with a consent agreement under which Buttar agreed to be reprimanded for treating an out-of-state autistic child whom he had never examined and the board all other pending charges [23].

In 2007, the Pennsylvania Board of Medicine temporarily suspended the license of Roy Kerry, M.D. following the death of a a 5-year-old autistic child to whom he administered chelation therapy [24]. In 2009, Kerry signed a consent order under which he was suspended for six more months, to be followed by 2 1/2 years of probation. He was also barred from chelating children under age 18 in the future. [25] Kerry was also sued by the victim's parents [26].

In 2008, The Texas Medical Board began investigating Jesus Caquias, medical director of the now-defunct CARE Clinics in Austin Texas. No public documents have been released, but the clinic owner mentioned the investigation during a newspaper interview [27].

In 2009, 43-year-old Ronald Stemp sued Jesus Caquias, CARE Clinics, the clinic's owner, and Doctor's Data for fraud, negligence, and conspiracy. The suit petition states that Stemp originally sought help for memory loss, inability to sleep, difficulty concentrating, and depression. After taking a urine toxic metals test and several other tests, he was falsely diagnosed with heavy metal poisoning and advised to undergo intravenous chelation therapy. Stemp's insurance company was reportedly billed for a total of $180,000 [28]. Caquias is also facing charges from the Texas Medical Board [29].

In February 2010, Vincy Tidwell, Jr, a former patient, charged Dr. Buttar with violating North Carolina's Unfair and Deceptive Trade Practices Act by fraudulently representing that "detoxification" would cure Tidwell's prostate cancer [30].

In February 2010, in a suit against naturopath Mathew Schlechten, a Montana jury awarded $501,007.68 to the widow of John Sisson, who died of a heart attack at age 52 [31]. Testimony in the case indicated that although Schlechten knew that Sisson had anginal pain, he failed to refer him for medical evaluation. Instead he administered chelation therapy after using a provoked urine test to persuade Sisson that he was toxic.

In March 2010, James Coman filed suit on behalf of his 7-year-old son against Anju Usman, M.D., Daniel Rossignol, M.D., and Doctor's Data. Among other things, the complaint indicated that—based on the results of provoked urine testing—the boy was inappropriately treated for nonexistent metal toxicity for more than four years [32].

In May 2010, the Texas Medical Board charged "autism specialist" Seshagiri Rao, M.D. with nontherapeutic prescribing, failure to secure informed consent, and fraudulent billing related to his mismanagement of five children with autism or autism spectrum disorder. The complaint states that Rao used an inappropriate urine test to diagnose nonexistent "heavy metal toxicity," inappropriately treated the patients with chelation therapy, and pretended to insurance companies that he was treating heavy metal toxicity rather than autism [33].

Licensing boards are considering other complaints against doctors in Florida and Illinois.

The Bottom Line

The urine toxic metals test described above—whether provoked or not—is used to persuade patients they are toxic when they are not. I believe that several agencies can and should do something to stop this deception.

If the FDA has jurisdiction over the software used to generate the test reports, it could ban its use. State licensing boards could prohibit the use of provoked testing and discipline practitioners who use it.

State laboratory licensing agencies could prohibit testing of provoked specimens or order Doctor's Data to raise its reference ranges and to stop comparing provoked test results to these non-provoked ranges.

The Centers for Medicare & Medicaid Services' Division of Laboratory Services can also ban the testing of provoked specimens.

State attorneys general can seek injunctions based on violations of consumer protection laws.

In addition, all of these agencies can and should issue public warnings.

People who have been victimized can also strike back. Practitioners who prescribe or administer chelation based on a urine toxic metal test report can be sued for malpractice, fraud, and battery, and might even be liable for violating their state Unfair Trade Practices Act, which can result in an award of triple damages. Consumers can also complain to the Better Business Bureau about the test.

I recommend avoiding any practitioner who uses the urine toxic metals test as described above. If this test has been used to trick you,
and include your phone number.

Doctor's Data does not like this report. After I refused to their demand to remove it, they sued me. To read about the suit, click here.

First amended statement of charges. In the matter of the license to practice as a physician and surgeon of Stephen L. Smith, M.D. Washington Department of Health, Bureau of Medical Quality Assurance, Docket No. 05-01-A-1038MD, Filed Jan 3, 2006.

Final order. In the matter of Joseph Edward Rich before the Tennessee Board of Medical Examiners, Docket No. 17.18-073557A, Dec 21, 2007.

Complaint. In the matter of the complaint against William James Rea before the Texas Medical Board. Filed Aug 27, 2007.